Sinopharm's mRNA Omicron vaccine gets greenlight for trials

China National Biotec Group, a subsidiary of China National Pharmaceutical Group Co Ltd (Sinopharm), announced on Friday that its biotech unit in Shanghai has received regulatory approval for clinical trials of China's first mRNA COVID-19 vaccine targeting the Omicron strains.

The approval for Omicron-specific mRNA vaccine clinical trials, granted by the State Drug Administration on Thursday, is a "milestone" in the company's COVID-19 vaccine development after producing inactivated and genetic recombinant vaccines, Zhang Yuntao, vice-president and chief scientist of the group, said in a statement.

"From the early stage of research and development, CNBG has been working toward developing a world-class Omicron-specific mRNA vaccine in all aspects. Also, we have been making efforts to speed up the process for clinical trials," Zhang said.

CNBG began research on and development of Omicron-specific vaccines near the end of 2021, Gao had previously said.

Jia Weiguo, chief scientist at CNBG's Virogin Biotech Company, said the new mRNA vaccine, which can encode the full-length of the Omicron variant's S protein, could help the body to create antibodies more efficiently. It has proved effective in preventing infection in animal trials.

"The company's advanced mRNA-LNP encapsulation technology can further guarantee the production capacity of the vaccine," Jia said.

Virogin, which is based in Shanghai, has built a research and development platform, as well as production lines with an annual capacity of 2 billion doses of mRNA vaccine. They can quickly produce mRNA vaccines to deal with pandemics, CNBG said.

The company added that it will further assess the safety, immunogenicity and effectiveness of production during clinical trials.

According to the Ministry of Industry and Information Technology, China's annual COVID-19 vaccine production capacity has reached 7 billion doses, and the annual output exceeded 5.5 billion doses in 2022, which is a big improvement compared with the capacity of 5 billion doses in 2021.

Gao Fu, former head of the Chinese Center for Disease Control and Prevention, said in an interview with China Newsweek that vaccines against the mutant strains of COVID-19 should be approved for use as soon as possible.

Gao suggested that approval procedures for COVID-19 vaccines should be similar to those for influenza vaccines. If the vaccines come from the same company and use the same technology, there's no need for them to go through the whole clinical trial process, as long as they are only different in strain or gene sequence, according to the China Newsweek report published on Thursday.

Gao added that although breakthrough infections are common, vaccination can still provide protection, and that the elderly may need to get vaccinated every six months because of the possibility that COVID-19 could become an endemic disease over the long term.